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Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy

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Trial Conditions
  • Multiple Sclerosis
What is the purpose of this trial?

The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.

Date & Status


Who can Participate?


0 and older



Inclusion Criteria:

- Patients that as part of their routine clinical care and according to the locally
approved label, are either;

- Starting fingolimod at time of study entry.

- Starting another approved DMT or started within maximum 6 months prior to study

- Patients, or a able legal representative of the patient, who are willing to provide
written informed consent.

Fingolimod patients will constitute the fingolimod cohort while patients with the other
DMT will constitute the parallel cohort

Exclusion Criteria:

- Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone,
cladribine, alemtuzumab) or natalizumab

- Patients participating simultaneously in another study with inclusion/exclusion
criteria more restrictive than the label or an interventional study unless this is a
study on fingolimod lasting 1 month maximum

Other protocol-defined inclusion/exclusion criteria may apply

Gender: Both
Steward Physician(s)
  • Novartis Pharmaceuticals
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
  • Fingolimod
  • other disease-modifying therapy
Physician Researcher

Investigator Name:

  • Novartis Pharmaceuticals

Other Information

Sponsor: Novartis
Phase: N/A
Trial ID: NCT01442194
Volunteers:  Not Accepting Healthy Volunteers

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